IMG-7289 in Patients With Myelofibrosis
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03136185 |
Recruitment Status :
Recruiting
First Posted : May 2, 2017
Last Update Posted : February 17, 2021
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This is a Phase 2b open label study of an orally administered LSD1 inhibitor, IMG-7289, in patients with myelofibrosis.
This study investigates the following:
- The safety and tolerability of IMG-7289
- The pharmacokinetics of IMG-7289 (performed in Phase 1/2a only)
- The pharmacodynamic effect of IMG-7289
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Myelofibrosis Post-polycythemia Vera Myelofibrosis (PPV-MF) Post-essential Thrombocythemia Myelofibrosis (PET-MF) Primary Myelofibrosis (PMF) | Drug: IMG-7289 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 75 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Multi-Center, Open Label Study to Assess the Safety, Steady-State Pharmacokinetics and Pharmacodynamics of IMG-7289 in Patients With Myelofibrosis |
Actual Study Start Date : | July 1, 2017 |
Estimated Primary Completion Date : | December 2021 |
Estimated Study Completion Date : | February 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: IMG-7289
Single starting dose with individualized dose titrations throughout
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Drug: IMG-7289
Differentiation therapy
Other Name: LSD1 inhibitor |
- Incidence of treatment-emergent adverse events, and changes in physical examination, vital signs and laboratory parameters [safety and tolerability] [ Time Frame: Assessed from the time of first dose through 28 days after end of treatment. ]as measured by the frequent monitoring of: adverse events, physical examination and vital signs and laboratory parameters.
- Drug Concentration (performed in Phase 1/2a only) [ Time Frame: Up to 3 months. ]as measured by Cmin sampling.
- Spleen Volume [ Time Frame: Baseline to each visit where the variable is measured. ]Reduction in spleen volume based on MRI (or CT)

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- >18 years
- Diagnosis of either PMF per World Health Organization (WHO) diagnostic criteria for myeloproliferative neoplasms, PPV-MF or PET-MF per the IWG-MRT
- High or intermediate-2 risk disease, as defined per protocol
Exclusion Criteria:
- Receiving other treatments for the condition (with exceptions and time limits)
- Major surgery in last 4 weeks, minor surgery in the last 2 weeks
- History of, or scheduled, hematopoietic stem cell transplant within 24 weeks of Screening
- History of splenectomy
- Current use of prohibited medications
- A concurrent second active and nonstable malignancy
- Known HIV infection or active Hepatitis B or Hepatitis C virus infection
- Other hematologic/biochemistry requirements, as per protocol
- Use of investigational agent within last 14 days
- Pregnant or lactating females

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03136185
Contact: Jennifer Peppe | +1-415-529-5055 | jennifer.peppe@imagobio.com | |
Contact: Amber Jones | amber.jones@imagobio.com |
United States, Michigan | |
University of Michigan | Recruiting |
Ann Arbor, Michigan, United States, 48105 | |
Contact: Kristen Pettit, MD 734-647-8901 krpettit@med.umich.edu | |
Australia, South Australia | |
Royal Adelaide Hospital | Completed |
Adelaide, South Australia, Australia | |
Germany | |
Universitatsklinikum Essen | Recruiting |
Essen, Germany, 45147 | |
Contact: Joachim Goethert, MD 0201 723 84706 | |
Italy | |
Azienda Ospedaliero Universitaria Careggi | Recruiting |
Florence, Italy | |
Contact: Alessandro M Vannucchi 390557947688 | |
United Kingdom | |
Guy's and St Thomas' Hospitals | Recruiting |
London, United Kingdom | |
Contact: Claire Harrison 020 7188 4259 HaematologyResearchTeam@gstt.nhs.uk |
Principal Investigator: | Kristen Pettit | University of Michigan |
Responsible Party: | Imago BioSciences,Inc. |
ClinicalTrials.gov Identifier: | NCT03136185 |
Other Study ID Numbers: |
IMG-7289-CTP-102 |
First Posted: | May 2, 2017 Key Record Dates |
Last Update Posted: | February 17, 2021 |
Last Verified: | February 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
LSD1 |
Polycythemia Vera Primary Myelofibrosis Polycythemia Thrombocytosis Thrombocythemia, Essential Myeloproliferative Disorders Bone Marrow Diseases Hematologic Diseases |
Bone Marrow Neoplasms Hematologic Neoplasms Neoplasms by Site Neoplasms Blood Platelet Disorders Blood Coagulation Disorders Hemorrhagic Disorders |